Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 ) FDA label
Also known as Ra-223, BAY 88-8223, Radium 223 Dichloride, Xofigo
Radium-223 · 2 trials · 4 indications
The proportion of patients who achieve a greater than 50% decline from baseline prostate specific antigen (PSA) (PSA50) drawn prior to C1D1, at any point in the treatment course, will be descriptively reported along with 95% binomial confidence interval. It will be compared with the historical control by binomial test. A confirmation repeat PSA will be drawn after the initial PSA50 response to confirm the result. A PSA50 will only be counted if two PSA showing a 50% decline are measured.
Time to progression in men who have oligometastatic prostate cancer after therapy. Progression is defined by PCWG2 criteria as follows: \>=25% increase in PSA from nadir (and by \>=2ng/mL), and/or clinical/radiographic progression (clinical progression = symptomatic progression, worsening of disease-related symptoms or new cancer-related complications; radiographic progression on CT scan defined by RECIST 1.1 criteria: \>=20% enlargement in sum diameter of soft-tissue target lesions; or on bone scan \>=1 new bone lesions), initiation of ADT or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Treatment (NaF PET/CT/MDP, Ra-223, PSMA PET) | EXPERIMENTAL | Patients undergo NaF PET/CT or MDP scan within 45 days prior to cycle 1 day 1. Patients then receive standard of care Ra-223 IV on day 1 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo PSMA PET/CT over 45-60 minutes between 30-60 days after the last dose of Ra-223. Patients also undergo collection of blood samples during screening, on day 1 of every Ra-223 cycle, and at 30 days after the last dose of Ra-223. Patients may also undergo NaF PET/CT or MDP scans during Ra-223 treatment as clinically indicated, and/or CT scans during screening and Ra-223 treatment as clinically indicated. |
| Radium-223 and SABR | EXPERIMENTAL | First radium-223 infusion will be within two weeks of SABR |
| SABR | ACTIVE_COMPARATOR | SABR(1-5 fractions) will be administered for all men |
| Name | Type | Description |
|---|---|---|
| Radium-223 | DRUG | Given IV |
| PSMA Positron Emission Tomography (PET) Scan | PROCEDURE | Undergo PSMA PET/CT |
| Technetium Tc 99M Medronate | DRUG | Undergo MDP |
| stereotactic ablative radiotherapy (SABR) | RADIATION | SABR 1-5 fractions |
Inclusion Criteria: * Male participants \>= 18 years of age on the day of signing informed consent * Castrate level of serum testosterone at study entry (\< 50 ng/dL), checked within three months of enrollment * Patient is a candidate for standard of care Ra-223 therapy * Bone only disease on PSMA ...